Clinical Trial: Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission for Determination of Compliance and/or Speed of Drug Metabolism
Brief Summary: Compliance with treatment is notoriously low in psychiatric patients. Traditional methods of monitoring compliance, however, may underreport nonadherence to treatment. In this study, actual plasma levels at admission - which are ROUTINELY taken at the Dept Psychiatry of the Paracelsus Medical University - were compared to plasma levels that can be expected from the prescribed preadmission dosing regimen. This was done to give treating psychiatrists a quantitatively precise idea of how frequently they can expect their patients to have plasma levels that are below the level of medication as intended by the prescribing physician.
Detailed Summary:
Context Noncompliance or incomplete compliance with psychopharmacological medication by psychiatric patients is a frequent risk and may be underreported by classical methods (e.g., pill counts or coloring additives).
Objective To determined the prevalence of incomplete compliance and/or faster-than average elimination of the medication by comparing actual plasma levels with those expected from the prescribed dosage under naturalistic routine conditions.
Design Forty-five day prospective routine survey.
Setting University acute inpatient clinic.
Participants All consecutive admissions for acute inpatient treatment from June 1, 2005 to July 15, 2005 who had been treated with antidepressants and/or antipsychotics.
Intervention Determination of plasma levels of all psychiatric medications and their comparison to the expected plasma levels, based on known preadmission dosing regimen and average pharmacokinetic data.
Main outcome measures The percentage of admissions with actual plasma level that were (a) more than 2-fold lower or (b) more than 2-fold higher than the expected plasma level or (c) differing only 0.5- to 2-fold from the expected plasma level.
Sponsor: Medical University Innsbruck
Current Primary Outcome: The percentage of admissions with actual plasma level that were (a) more than 2-fold lower or (b) more than 2-fold higher than the expected plasma level or (c) differing only 0.5- to 2-fold from the expected plasma level. [ Time Frame: at admission to psychiatric inpatient treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: There is NO secondary outcome measure. [ Time Frame: at admission ]
Original Secondary Outcome: Same as current
Information By: Medical University Innsbruck
Dates:
Date Received: February 22, 2008
Date Started: June 2005
Date Completion:
Last Updated: February 22, 2008
Last Verified: February 2008
